Our Approach
A poorly designed protocol is one of the most common — and most costly — sources of clinical trial failure. Ambiguous eligibility criteria, unrealistic endpoints, inadequate sample sizes, and regulatory misalignment can all derail a study before the first patient is enrolled. At Althian, we treat protocol development as one of the most critical investments a sponsor can make.
Whether you are starting from a blank page or refining an existing draft, our team works closely with you to design a protocol that is scientifically sound, operationally feasible, and fully aligned with COFEPRIS requirements and international standards. We bring over 15 years of on-the-ground experience in Mexico to every protocol we touch — which means we design for the reality of conducting research here, not just the theory.
What We Cover
We write protocols from scratch or work from a sponsor's existing draft to develop a complete, submission-ready document. Our team ensures the protocol clearly defines study objectives, endpoints, eligibility criteria, study procedures, and safety monitoring — with the level of precision that regulators and ethics committees expect.
Every protocol we develop is reviewed and adapted to ensure full alignment with COFEPRIS requirements and Mexican regulatory expectations. We identify and address potential regulatory gaps early — before submission — to minimize back-and-forth with health authorities and keep your timeline intact.
Our team develops the statistical analysis plan and sample size calculations in parallel with protocol development, ensuring the study is adequately powered and the analysis approach is aligned with the study objectives and regulatory requirements from day one.
Before a protocol is finalized, we conduct a thorough operational feasibility review to assess whether the design is realistic given the available patient population, site infrastructure, and timelines in Mexico. This step prevents the common disconnect between what a protocol requires on paper and what is actually achievable on the ground.
We prepare all supporting study documents, including informed consent forms, investigator brochures, and case report forms, ensuring they meet ethics committee and regulatory requirements and are adapted for the cultural and linguistic context of the Mexican patient population.
Why It Matters
Every decision made during a clinical trial — who gets enrolled, what data gets collected, how safety is monitored — flows from the protocol. A strong protocol gives investigators clarity, gives regulators confidence, and gives sponsors the foundation they need to generate data that will hold up in any market.
At Althian, we approach protocol development not as a document exercise but as a strategic one. We invest the time upfront so that the rest of the study can run smoothly.
Monterrey, México